A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
October 30, 2026 updated by: Vir Biotechnology, Inc.
A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montreal, Canada, H2X 1R9
- Investigative Site
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Ottawa, Canada, K1H8L6
- Investigative Site
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Québec, Canada, G1V 4G2
- Investigative Site
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Vancouver, Canada, V6Z 2C7
- Investigative Site
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Investigative Site
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Quebec
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Montreal, Quebec, Canada, H2L 4E9
- Investigative Site
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Tbilisi, Georgia, 0102
- Investigative Site
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Tbilisi, Georgia, 0114
- Investigative Site
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Tbilisi, Georgia, 0159
- Investigative Site
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Frankfurt, Germany, 60590
- Investigative Site
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Hanover, Germany, 30625
- Investigative Site
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Heidelberg, Germany, 69120
- Investigative Site
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Chisinau, Moldova, 2025
- Investigative Site
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Auckland, New Zealand, 1010
- Investigative Site
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Karachi, Pakistan, 74800
- Investigative Site
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Karachi, Pakistan, 75600
- Investigative Site
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Lahore, Pakistan, 54800
- Investigative Site
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Rawalpindi, Pakistan, 46000
- Investigative Site
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Bucharest, Romania, 021105
- Investigative Site
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Bucharest, Romania, 022328
- Investigative Site
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Bucharest, Romania, 030303
- Investigative Site
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Kyiv, Ukraine, 01135
- Investigative Site
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London, United Kingdom, SE5 9RS
- Investigative Site
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London, United Kingdom, E1 1BB
- Investigative Site
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Manchester, United Kingdom, M8 5RB
- Investigative Site
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Nottingham, United Kingdom, NG7 2UH
- Investigative Site
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Arizona
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Chandler, Arizona, United States, 85224
- Investigative Site
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California
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Los Angeles, California, United States, 90033
- Investigative Site
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Redwood City, California, United States, 94063
- Investigative Site
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San Francisco, California, United States, 94143
- Investigative Site
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Florida
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DeLand, Florida, United States, 32720
- Investigative Site
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Illinois
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Chicago, Illinois, United States, 60612
- Investigative Site
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Maryland
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Baltimore, Maryland, United States, 21287
- Investigative Site
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New Jersey
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Hillsborough, New Jersey, United States, 08844
- Investigative Site
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New York
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New York, New York, United States, 10029
- Investigative Site
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New York, New York, United States, 10016
- Investigative Site
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New York, New York, United States, 10021
- Investigative Site
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Utah
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Murray, Utah, United States, 84107
- Investigative Site
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Washington
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Seattle, Washington, United States, 98105
- Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ages 18 to 70 years at screening
- Chronic HDV infection for >/= 6 months
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 20 IU/ml at screening, currently on locally approved NRTI therapy
- Serum ALT > ULN and < 5x ULN
- Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
Exclusion Criteria:
- Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
- History of significant liver disease from non-HBV or non-HDV etiology
- History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
- History of anaphylaxis
- History of immune complex disease
- History of autoimmune disorder
- History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1 (Tobevibart + Elebsiran)
Participants will receive treatment with tobevibart + elebsiran for 240 weeks. |
Tobevibart administered by subcutaneous injection
Other Names:
Elebsiran administered by subcutaneous injection
Other Names:
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Experimental: Arm 2 (Tobevibart + Elebsiran)
Participants will receive tobevibart + elebsiran after an observational period for 240 weeks. |
Tobevibart administered by subcutaneous injection
Other Names:
Elebsiran administered by subcutaneous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
Time Frame: Up to 48 weeks
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Up to 48 weeks
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Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
Time Frame: Up to 48 weeks
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Up to 48 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2025
Primary Completion (Actual)
September 30, 2026
Study Completion (Estimated)
May 1, 2031
Study Registration Dates
First Submitted
March 24, 2025
First Submitted That Met QC Criteria
March 24, 2025
First Posted (Actual)
March 30, 2025
Study Record Updates
Last Update Posted (Actual)
November 3, 2026
Last Update Submitted That Met QC Criteria
October 30, 2026
Last Verified
October 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIR-CHDV-V203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.